EYLEA® HD (Aflibercept) Injection 8 mg Approved by FDA for Treatment of Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR); Approval Based on the Pivotal PULSAR and PHOTON Trials in Which EYLEA® HD Demonstrated Clinically Equivalent Vision Gains to EYLEA (Aflibercept) Injection 2 Mg That Were Maintained with Fewer Injections; First and Only Treatment Approved in wAMD and DME for Immediate Dosing at 8-Week and Up to 16-Week Intervals Following Three Initial Monthly Doses

On August 18, 2023, Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD (aflibercept) Injection 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) every 4 weeks (monthly) for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR. “The FDA approval of EYLEA HD is an important advancement in retinal care,” said Peter Kaiser, MD, Chaney Family Endowed Chair in Ophthalmology Research at the Cole Eye Institute and Professor of Ophthalmology at Cleveland Clinic Lerner College of Medicine. “With EYLEA HD, patients with wet age-related macular degeneration or diabetic retinal disease can now receive less frequent injections after their initial monthly doses and still experience the similar visual gains, anatomic improvements, and safety profile of EYLEA.”